amoxicillin

Generic: amoxicillin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amoxicillin
Generic Name amoxicillin
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amoxicillin 500 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-028
Product ID 57237-028_679691e2-bbbf-4ed0-a31b-e538b3df75c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065256
Listing Expiration 2026-12-31
Marketing Start 2005-11-09

Pharmacologic Class

Classes
penicillin-class antibacterial [epc] penicillins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237028
Hyphenated Format 57237-028

Supplemental Identifiers

RxCUI
308192 308194
UPC
0357237029015 0357237028018
UNII
804826J2HU

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amoxicillin (source: ndc)
Generic Name amoxicillin (source: ndc)
Application Number ANDA065256 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (57237-028-01)
  • 20 TABLET, FILM COATED in 1 BOTTLE (57237-028-20)
source: ndc

Packages (2)

Ingredients (1)

amoxicillin (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "679691e2-bbbf-4ed0-a31b-e538b3df75c0", "openfda": {"upc": ["0357237029015", "0357237028018"], "unii": ["804826J2HU"], "rxcui": ["308192", "308194"], "spl_set_id": ["bb7733f8-6aad-4273-84a0-ef472630203f"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (57237-028-01)", "package_ndc": "57237-028-01", "marketing_start_date": "20051109"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (57237-028-20)", "package_ndc": "57237-028-20", "marketing_start_date": "20051109"}], "brand_name": "Amoxicillin", "product_id": "57237-028_679691e2-bbbf-4ed0-a31b-e538b3df75c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]"], "product_ndc": "57237-028", "generic_name": "Amoxicillin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amoxicillin", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "500 mg/1"}], "application_number": "ANDA065256", "marketing_category": "ANDA", "marketing_start_date": "20051109", "listing_expiration_date": "20261231"}